search
Back to results

Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil (HEXAS)

Primary Purpose

Hypertension, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Normobaric hypoxia (FiO2 15%)
Placebo-ambient air (FiO2 21%)
Normobaric hypoxia (FiO2 15%) under Sildenafil
Placebo-ambient air (FiO2 21%) under Sildenafil
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring hypoxia, exercise, Sildenafil

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent as documented by signature (Appendix Informed Consent Form)
  • PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization

Exclusion Criteria:

  • resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air
  • exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study
  • inability to follow the procedures of the study
  • patients who take nitrates
  • other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)

Sites / Locations

  • University Hospital of Zurich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Sham Comparator

Experimental

Active Comparator

Arm Label

Normobaric hypoxia (FiO2 15%)

Placebo-ambient air (FiO2 21%)

Normobaric hypoxia (FiO2 15%) under Sildenafil

Placebo-ambient air (FiO2 21%) under Sildenafil

Arm Description

Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.

Outcomes

Primary Outcome Measures

mean pulmonary artery pressure (mPAP) / cardiac output (CO)
Difference in mPAP/CO during exercise between tests under normoxia/hypoxia with/without Sildenafil

Secondary Outcome Measures

Differences in pulmonary arterial pressure
Differences in pulmonary arterial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in cardiac output
Differences in cardiac output at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in pulmonary vascular resistance
Differences in pulmonary vascular resistance at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in pulmonary artery wedge pressure
Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in right atrial pressure
Differences in right atrial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in mixed venous oxygen saturation
Differences in mixed venous oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in heart rate
Differences in heart rate at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in blood pressure
Differences in blood pressure at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in oxygen saturation
Differences in oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Differences in arterial blood gases
Differences in arterial blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in mixed venous blood gases
Differences in mixed venous blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in cerebral tissue oxygenation
Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Differences in muscle tissue oxygenation
Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Differences in symptoms (Borg dyspnoea)
Differences in symptoms (Borg dyspnoea) at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Differences in symptoms (Borg leg effort)
Differences in symptoms (Borg leg effort) at rest and during exercise under normoxia/hypoxia with/without Sildenafil

Full Information

First Posted
January 7, 2021
Last Updated
June 5, 2023
Sponsor
University of Zurich
search

1. Study Identification

Unique Protocol Identification Number
NCT04704440
Brief Title
Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil
Acronym
HEXAS
Official Title
Hemodynamic Effects of Acute Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension: Single-center Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
May 31, 2023 (Actual)
Study Completion Date
May 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To study the effect of acute normobaric hypoxia during exercise in patients with pulmonary hypertension with/without Sildenafil

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Pulmonary
Keywords
hypoxia, exercise, Sildenafil

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normobaric hypoxia (FiO2 15%)
Arm Type
Experimental
Arm Description
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Arm Title
Placebo-ambient air (FiO2 21%)
Arm Type
Sham Comparator
Arm Description
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Arm Title
Normobaric hypoxia (FiO2 15%) under Sildenafil
Arm Type
Experimental
Arm Description
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Arm Title
Placebo-ambient air (FiO2 21%) under Sildenafil
Arm Type
Active Comparator
Arm Description
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Intervention Type
Other
Intervention Name(s)
Normobaric hypoxia (FiO2 15%)
Intervention Description
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Intervention Type
Other
Intervention Name(s)
Placebo-ambient air (FiO2 21%)
Intervention Description
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Intervention Type
Other
Intervention Name(s)
Normobaric hypoxia (FiO2 15%) under Sildenafil
Intervention Description
Inhalation of deoxygenated air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Intervention Type
Other
Intervention Name(s)
Placebo-ambient air (FiO2 21%) under Sildenafil
Intervention Description
Inhalation of room air through an altitude simulator ("Altitrainer"), for approx. 1/2 hour given by a facemask, first at rest and then during exercise.
Primary Outcome Measure Information:
Title
mean pulmonary artery pressure (mPAP) / cardiac output (CO)
Description
Difference in mPAP/CO during exercise between tests under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Differences in pulmonary arterial pressure
Description
Differences in pulmonary arterial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in cardiac output
Description
Differences in cardiac output at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in pulmonary vascular resistance
Description
Differences in pulmonary vascular resistance at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in pulmonary artery wedge pressure
Description
Differences in pulmonary artery wedge pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in right atrial pressure
Description
Differences in right atrial pressure at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in mixed venous oxygen saturation
Description
Differences in mixed venous oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in heart rate
Description
Differences in heart rate at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in blood pressure
Description
Differences in blood pressure at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in oxygen saturation
Description
Differences in oxygen saturation at rest and during exercise, under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in arterial blood gases
Description
Differences in arterial blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in mixed venous blood gases
Description
Differences in mixed venous blood gases at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in cerebral tissue oxygenation
Description
Differences in cerebral tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in muscle tissue oxygenation
Description
Differences in muscle tissue oxygenation at rest and during exercise, with normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in symptoms (Borg dyspnoea)
Description
Differences in symptoms (Borg dyspnoea) at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours
Title
Differences in symptoms (Borg leg effort)
Description
Differences in symptoms (Borg leg effort) at rest and during exercise under normoxia/hypoxia with/without Sildenafil
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent as documented by signature (Appendix Informed Consent Form) PH class I (PAH) or IV (CTEPH) diagnosed according to guidelines: mean pulmonary artery pressure >20 mmHg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmHg during baseline measures at the diagnostic right-heart catheterization Exclusion Criteria: resting partial pressure of oxygen <8 kilopascal at Zürich altitude on ambient air exposure to an altitude >1000 m for ≥3 nights during the last 2 weeks before the study inability to follow the procedures of the study patients who take nitrates other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Ulrich, Prof. Dr.
Organizational Affiliation
UniversityHospital Zurich, Department of Pulmonology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We will share individual participant data after publication of the manuscript. The decision about the platform is ongoing.
IPD Sharing Time Frame
After publication of the manuscript.

Learn more about this trial

Effects of Normobaric Hypoxia During Exercise in Patients With Pulmonary Hypertension With/Without Sildenafil

We'll reach out to this number within 24 hrs